PropofolNCT06907823
Comparison of Sevoflurane and Propofol on ANI
A study testing propofol and Sevoflurane in people with Propofol and Sevoflurane, run by Pusan National University Yangsan Hospital.
Trial summary
The goal of this clinical trial is to compare the effect of sevoflurane and propofol on analgesia nociception index(ANI) in patients undergoing general anesthesia. The main question it aims to answer is whether propofol anesthesia results in lesser ANI change to a nociceptive stimulation compared to sevoflurane. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Propofol, Sevoflurane, Analgesia Nociception Index
- What is being tested?
- propofol and Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American society of anesthesiologists physical status class I or II
Who cannot join
- history of drugs that can affect the central nervous system and autonomic nervous system, such as anticholinergics, betablockers, antidepressants..etc.
- history of allergic reaction to sevoflurane and/or propofol
- history of and/or family history of malignant hyperthermia
- neurodegenerative disorder
- psychiatric disorder
- arrhythmia
- diabetes mellitus
- drug abuse history
About this study
Official title: Comparison of Sevoflurane and Propofol on ANI in Patients Undergoing General Anesthesia: a Prospective Randomized Controlled Study
The goal of this clinical trial is to compare the effect of sevoflurane and propofol on analgesia nociception index(ANI) in patients undergoing general anesthesia. The main question it aims to answer is whether propofol anesthesia results in lesser ANI change to a nociceptive stimulation compared to sevoflurane.
Read the detailed description
Patients will be allocated to either propofol or sevoflurane group. Nociceptive event will be defined as long-lasting tetanic stimulation, square-wave, duration of 30 seconds , amplitude of 50mA, frequency of 50 Hz. analgesia nociception index value and hemodynamic parameters will be recorded 1-minute before and after nociceptive event.
- Conditions
- Propofol, Sevoflurane, Analgesia Nociception Index
- Being tested
- propofol, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
propofol anesthesia
SevofluraneDrug
sevoflurane anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Other | Not described Receives: Drug: Sevoflurane |
| Propofol | Other | Not described Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesia nociception index change
analgesia nociception index value 1-minute before tetanic stimulation and 1-minute after tetanic stimulation
Measured: During anesthesia period
Secondary outcomes (2)
Hemodynamic change
Blood pressure change 1 minute before tetanic stimuation and 1 minute after tetanic stimulation
Measured: During anesthesia period
Hemodynamic change
Heart rate change before 1-minute before nociceptive stimuli and 1-minute after nociceptive stimuli
Measured: During anesthesia period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start30 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PropofolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jimin Lee, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907823
- Sponsor's protocol ID
- 11-2025-003
- Status last verified
- Jun 2025
- First submitted
- 28 Mar 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sevoflurane and Propofol on ANI in Patients Undergoing General Anesthesia: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06907823
- Acronym / sponsor ID
- 11-2025-003
- Conditions
- Propofol, Sevoflurane, Analgesia Nociception Index
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare the effect of sevoflurane and propofol on analgesia nociception index(ANI) in patients undergoing general anesthesia. The main question it aims to answer is whether propofol anesthesia results in lesser ANI change to a nociceptive stimulation compared to sevoflurane.
Detailed description
Patients will be allocated to either propofol or sevoflurane group. Nociceptive event will be defined as long-lasting tetanic stimulation, square-wave, duration of 30 seconds , amplitude of 50mA, frequency of 50 Hz. analgesia nociception index value and hemodynamic parameters will be recorded 1-minute before and after nociceptive event.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Other | Drug: Sevoflurane |
| Propofol | Other | Drug: propofol |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American society of anesthesiologists physical status class I or II
Key exclusion criteria (8 listed)
- history of drugs that can affect the central nervous system and autonomic nervous system, such as anticholinergics, betablockers, antidepressants..etc.
- history of allergic reaction to sevoflurane and/or propofol
- history of and/or family history of malignant hyperthermia
- neurodegenerative disorder
- psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolpropofol anesthesia | Drug | Propofol |
| Sevofluranesevoflurane anesthesia | Drug | Sevoflurane |
Primary outcome
analgesia nociception index change
Time frame: During anesthesia period
analgesia nociception index value 1-minute before tetanic stimulation and 1-minute after tetanic stimulation
2 secondary outcomes
Hemodynamic change
Time frame: During anesthesia period
Hemodynamic change
Time frame: During anesthesia period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing propofol and Sevoflurane in people with Propofol and Sevoflurane, run by Pusan National University Yangsan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analgesia nociception index change (time frame: During anesthesia period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.